Urological procedures, such as operations and/or pathology on the bladder and prostate, are commonly performed. A complication that may arise as a result of such urological procedures being performed, or as a result of diseases of the bladder or prostate, is the accumulation and retention of clots in the bladder or prostate.
The presence of these clots, and the danger they potentially pose to a patient, have been known for decades. Many techniques and associated devices have been employed in order to eliminate these bladder clots. Most techniques involve the insertion of catheters to irrigate and then evacuate the clots. For example, one specific technique involves the insertion of a 3-way Foley catheter to irrigate the bladder followed by the replacement of the Foley catheter with a Whistle tip catheter to further irrigate the bladder and suction away clots.
While this clot evacuation technique usually works for its intended purpose, it is replete with disadvantages and associated problems involving patient discomfort, duration, cost and risk. For example, the insertion and removal of a catheter on two separate occasions during one procedure increases the likelihood of triggering acute senses of invasiveness and discomfort in a patient. Also, when especially large clots are present and need to be evacuated, correspondingly large catheters must be used, thus necessitating the use of general anesthesia.
Another problem with this, and other techniques that employ more than one catheter, is that certain remote but realistic risks to a patient arise upon each insertion of a catheter (i.e., bladder injury or rupture, bacteremia) and accompany any usage of general anesthesia (i.e., allergic reaction by the patient, overdose). Furthermore, these prior art clot evacuation techniques are costly due to the surgical time required and the use of general anesthesia.
Another technique for eliminating clots in the bladder or prostate is to cut the clots with a catheter equipped with cutting blades. Catheters equipped with cutting blades, however, have yet to adequately reconcile safety issues with performance issues. For example, large and powerful blades are required to cut large bladder clots; however, such catheters do not adequately protect the bladder wall from being cut while the blade is active.
Various clot evacuation catheters are shown and described in U.S. Pat. Nos. 4,020,847 (to Clark, III); 4,631,052 (to Kensey); 4,754,755 (to Husted); 4,790,812 (to Hawkins, Jr. et al.); 5,520,635 (to Gelbfish) and 5,643,296 (to Hundertmark).
A need remains, however, for a catheter which will enable the effective removal of clots of varying size from the bladder and/or prostate while minimizing the cost and duration of the process, and the discomfort and risk of harm to the patient during the process.